India Strengthens International Cooperation in Medical Product Regulation

The Union Cabinet has been apprised of Memorandums of Intent (MoIs) and Understanding (MoUs) signed between the Central Drugs Standard Control Organization (CDSCO) and regulatory bodies from the Netherlands, the Dominican Republic and the Republic of Ecuador. These agreements focus on cooperation in the field of Medical Products Regulation.

CDSCO Launches National Single Window System Portal

This portal has been designed to build a system that functions as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business. The NSWS Portal for CDSCO will be independent of the SUGAM Portal or the cdscomdonline portal.

Drug Alert List for November 2023

A total of 1197 samples were tested by the CDSCO. Based on the samples tested, CDSCO has found a total of 64 drugs, medical devices and cosmetics that are identified as being deficient.

CDSCO classifies In-Vitro Diagnostic Medical Devices under Medical Device Rules, 2017

This classification has been undertaken on the basis of intended use, risk associated with the device and other parameters. CDSCO has updated its List of In-Vitro Diagnostic Medical Devices (IVD Analyzers) and List of In-Vitro Diagnostic Medical Devices (IVD Instruments). It has also added List of In-Vitro Diagnostic Medical Devices (IVD- Specimen receptacle) and List of In-Vitro Diagnostic Medical Devices under provisions of sub-rule (2) rule 4 of the Medical Devices Rules, 2017.

Medical Devices (Amendment) Rules, 2023

These Rules aim to enhance the regulatory framework governing medical devices in the country. They provide for the establishment and designation of State Medical Devices Testing Laboratories, further empowering the testing and evaluation of medical devices.